Principal Regulatory Affairs Specialist - Global Regulatory - Supplier Quality

Boston Scientific - Saint Paul, MN

Full-time - Mid Level

Hybrid - Saint Paul, MN

Miscellaneous Manufacturing

About the position

The Regulatory professional will serve as the primary Regulatory Affairs representative for projects related to Supplier Quality and Material Controls. This role involves collaboration with cross-functional teams to ensure compliance and support quality system projects, process changes, and audit support. The position is hybrid, requiring a minimum of three days in the office, with flexibility in location between Arden Hills, Marlborough, MA, or Galway, Ireland.

Responsibilities

• Act as the Regulatory Affairs Lead on Supplier Quality and Material Controls initiatives.
• Collaborate with cross-functional partners to deliver innovative compliance solutions.
• Identify process gaps and opportunities for efficiencies in supplier change enhancement projects.
• Participate in Quality System Community of Practice forums as a Regulatory Affairs representative.
• Influence global partners in understanding new regulatory concepts and best practices.
• Engage in advocacy streams to monitor regulation trends and benchmark against industry leaders.
• Author, revise, and edit standard operating procedures and work instructions.
• Serve as the Regulatory Affairs SME in assessments for global requirement changes.
• Coordinate regulatory strategy and execute deliverables for manufacturing process changes.
• Train and mentor staff in regulatory affairs and quality systems development.

Requirements

• Minimum of a Bachelor's degree.
• At least 5 years of experience in Regulatory Affairs or related fields within the medical device, IVD, pharmaceutical, or healthcare industries.
• Experience with Supplier Engineering, Supplier Quality, or Material Controls.
• Working knowledge of FDA, EU, and international medical device regulations.
• Ability to read and interpret global regulations and standards.
• General understanding of product development processes and quality system regulations.
• Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint).

Nice-to-haves

• Degree or work experience in a scientific or technical discipline.
• Experience managing complex matrixed organizational structures.
• Excellent written and oral communication, technical writing, and editing skills.
• Strong research and analytical skills.
• Experience with audits from regulatory bodies (e.g., MDSAP and ISO 13485).
• Ability to manage multiple projects simultaneously.
• High sense of urgency and commitment to execution.
• Proven leadership, collaboration, and influencing skills.

Benefits

• Access to the latest tools and training for career advancement.
• Support for professional development and skill enhancement.